member memos

You may have seen the news last week that the Food and Drug Administration issued a consumer warning in addition to three warning letters regarding selective androgen receptor modulators (SARMs) being sold in bodybuilding products and illegally marketed as dietary supplements (see Natural Products Insider’s coverage here). The products are unapproved drugs that have not been reviewed by FDA for safety and effectiveness.

According to FDA, individuals who have taken products containing SARMs have suffered-life threatening reactions, including liver toxicity. SARMs also could increase the risk of heart attack and stroke, and their long-term effects on the body are unknown, the agency noted.

In response, the five major trade associations serving the natural products industry have joined with the U.S. Anti-Doping Agency (USADA) in today issuing the enclosed press release to consumer and industry trade media, in support of FDA’s action and to reiterate to consumers that products containing SARMs are illegal and unsafe.

As SARMs are sold under a variety of names, it is often difficult for industry or consumers to properly identify SARMs. USADA has provided the following list of ingredients that contain SARMs. We strongly encourage all of our member companies to ensure that they are not including these ingredients or any others containing SARMs.

Please let us know if you have any questions about this serious health issue.

Kind regards,LDI

Dietary Supplement Industry and U.S. Anti-Doping Agency Warn Consumers about Dangerous, Illegal Ingredients Known as SARMs—Groups support strict enforcement action by FDA--Washington, D.C., November 8, 2017--The dietary supplement industry’s leading trade associations and the U.S. Anti-Doping Agency (USADA) today joined in support of the U.S. Food and Drug Administration’s (FDA) recent actions to protect consumers from body-building products containing Selective Androgen Receptor Modulators (SARMs) illegally marketed as dietary supplements. SARMs are dangerous and illegal, and they pose an immediate risk to consumers, jeopardize the careers of athletes, and have no place in any sports nutrition regimen.

Together, the American Herbal Products Association (AHPA), the Consumer Healthcare Products Association (CHPA), the Council for Responsible Nutrition (CRN), the Natural Products Association (NPA), the United Natural Products Alliance (UNPA), and USADA share concerns about these products and are supporting FDA’s efforts to crack down on companies unlawfully manufacturing products containing SARMs.

As recognized in a recent FDA advisory, products containing these ingredients are not dietary supplements; they are unapproved drugs that have not been reviewed by the FDA for safety and effectiveness.

Prohibited under the S1 Anabolic Agent category of the World Anti-Doping Agency (WADA) Prohibited List, SARMs have raised serious concerns for FDA, USADA, and the legitimate dietary supplement industry, as they have the potential to be misused for athletic performance enhancement due to their anabolic properties and their ability to stimulate androgen receptors in muscle and bone. SARMs are not approved for human use or consumption in the United States, but, despite being prohibited, SARMs have been found in a number of adulterated products falsely labeled as dietary supplements. Some products list the ingredient as “Ostarine”—one ingredient in the class of SARMs—but the ingredients may also go by an alternative name, or be entirely undisclosed on the label.

In addition to alerting consumers, the five supplement industry trade associations have taken action to remind member companies of the responsibility to ensure that SARMs are not used in their products. USADA issues educational resources on an ongoing basis to warn athletes and sports organizations of the negative consequences resulting from using products that contain SARMs, including sanctions and suspension. The industry groups and USADA are committed to amplifying consumer alerts/warnings issued by FDA, and to disseminating tips consumers can use to make smart decisions when choosing sports nutrition products.

FDA regulates the dietary supplement industry and this advisory puts companies on notice that those failing to comply with the law are subject to strict enforcement actions. Additionally, the advisory serves as a reminder to consumers—particularly amateur and elite athletes—to educate themselves on the dangers SARMs-tainted products pose. There are legitimate sports nutrition dietary supplements that are safe, beneficial, and not prohibited by WADA, and it is important for all consumers, including athletes, to engage in due diligence when deciding which products to use and which companies to purchase products from. Further, consumers should maintain an open dialogue with healthcare practitioners, and, as appropriate, trusted coaches and trainers, when incorporating products into their training programs or performance goals. Finally, consumers would be wise to manage expectations for their sports nutrition supplement products and should not purchase dietary supplements claiming to have drug-like effects.###The American Herbal Products Association (AHPA) is the national trade association and voice of the herbal and botanical products industry. AHPA is comprised of more than 300 domestic and foreign companies doing business as growers, processors, manufacturers, and marketers of herbs and herbal products, including foods, dietary supplements, cosmetics, and non-prescription drugs. Founded in 1982, AHPA's mission is to promote the responsible commerce of herbal products. Website: www.ahpa.org.

The Consumer Healthcare Products Association (CHPA) is the 136-year-old trade association representing the leading manufacturers and marketers of over-the-counter (OTC) medicines and dietary supplements. Every dollar spent by consumers on OTC medicines saves the U.S. healthcare system $6-$7, contributing a total of $102 billion in savings each year. CHPA is committed to empowering consumer self-care by preserving and expanding choice and availability of consumer healthcare products. Visit www.chpa.org and www.KnowYourOTCs.org.

The Council for Responsible Nutrition (CRN), founded in 1973, is a Washington, D.C.-based trade association representing 150+ dietary supplement and functional food manufacturers, ingredient suppliers and companies providing services to those manufacturers and suppliers. In addition to complying with a host of federal and state regulations governing dietary supplements and food in the areas of manufacturing, marketing, quality control and safety, our manufacturer and supplier members also agree to adhere to additional voluntary guidelines as well as to CRN’s Code of Ethics. Visit www.crnusa.org. Follow us on Twitter @CRN_Supplementsand LinkedIn.

The Natural Products Association (NPA) is the trade association representing the entire natural products industry. We advocate for our members who supply, manufacture and sell natural ingredients or products for consumers. NPA has set numerous industry standards, such as dietary supplement Good Manufacturing Practices (GMPs), as well as a definition of natural for home care and personal care products. NPA, which represents over 1,100 members accounting for more than 10,000 locations of retailers, manufacturers, wholesalers and distributors of natural products, including natural/organic foods, dietary supplements, and health/beauty aids, has led the charge to keep the natural products industry in business for 81 years. Visit www.NPAinfo.org.

The United Natural Products Alliance (UNPA) is an international trade association representing more than 100 leading natural products, dietary supplement, functional food, scientific and technology and related service companies that share a commitment to provide consumers with natural health products of superior quality, benefit and reliability. Founded in Utah in 1992, UNPA was instrumental in the passage of the 1994 Dietary Supplement Health and Education Act (DSHEA) and continues to take a leadership position in legislative and regulatory issues and industry best practices. Visit www.unpa.com.

The U.S. Anti-Doping Agency (USADA) is the national anti-doping organization (NADO) in the United States for Olympic, Paralympic, Pan American, and Parapan American sport. The organization is charged with managing the anti-doping program, including in-competition and out-of-competition testing, results management processes, drug reference resources, and athlete education for all United States Olympic Committee (USOC) recognized sport national governing bodies, their athletes, and events. Additionally, USADA contributes to the advancement of clean sport through scientific research and education & outreach initiatives focused on awareness and prevention. Visit www.usada.org.